MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLES - BD LUER-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305784
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the after drawing up medication using the bd eclipse¿ needles - bd luer-lok¿ syringe, a leakage occurred at the threaded junction point.Found during use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
3 pcs representative samples were received in sealed package.All the samples were subjected to leak test and passed the test.A device history record review showed no non-conformances associated with this issue during the production of this batch.3 pcs representative samples were returned and subjected to leak test.All samples passed the test.Hence, root cause could not be determined.Continue to monitor the nonconformance trend.The representative samples passed the leak test.Continue to monitor the nonconformance trend.

• Brand Name: BD ECLIPSE¿ NEEDLES - BD LUER-LOK¿ SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7591338
• Report Number: 8041187-2018-00188
• Device Sequence Number: 16618859
• Product Code: FMI
• UDI-Device Identifier: 00382903057849
• UDI-Public: 00382903057849
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 305784
• Device Lot Number: 8052065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other